Evaluation of Sores Treatment by Oxygenotherapy

Ulcer Venous Clinical Trial

Official title:

Evaluation of Sores Treatment by Oxygenotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03200353
• Other study ID #: NATROX
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Every 2 days a nurse renew the application at home and patient recharge the system with oxygen every day. The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to have a consultation with the doctor.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: December 31, 2023
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years
• accepted to participate
• Patients followed in vascular medicine and entrusted to the home medical care for the bandages of chronic wounds with apathetic ulcers, not presenting of granulation tissue on their surface

Exclusion Criteria:

• infected ulcers
• necrosed ulcers
• Arterial ulcers requiring a revascularisation.
• Ulcers whose surface is superior in 10x10 cm.

Related Conditions & MeSH terms

• Ulcer Venous
• Varicose Ulcer

Intervention

Device:
• system NATROX (device name)
system NATROX (device name) application on the wounds of lower limbs

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care	Patients who have received the entire treatment.	4 weeks
Secondary	percentage of patients who can receive skin graft after the therapy	patient eligible to skin graft after the therapy indicate the success of the NATROX system	1-2 month
Secondary	percentage of patient who stopper the treatment	number of patients who have to stop the treatment because of non tolerability among all included patient	4 weeks